Varios P10Recalls & reported problems
Nakanishi Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264563254), received between Jun 10, 2025 and Jun 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
ON MAY 14, 2025, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR (B)(4) ABOUT A PATIENT'S ACCIDENTAL INGESTION OF AN NSK SCALER TIP. THE DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST WAS PERFORMING A PROPHYLAXIS CLEANING ON A PATIENT USING THE P10 SCALER TIP (LOT NO. UNKNOWN) WITH AN ULTRASONIC BUILT INTO CHAIR (A-DEC), ACTEON (SATELEC BRAND) SPEED 5 (MID SPEED SETTING). - DURING THE PROCEDURE, THE SCALER TIP FRACTURED AT THE SHANK, AND THE PATIENT SWALLOWED THE TIP. - THE PATIENT WENT TO THE HOSPITAL EMERGENCY ROOM AT 8PM ON (B)(6) 2025 AND WAS DISCHARGED AT 10PM. - X-RAYS CONFIRMED THE TIP TRAVELED TO THE STOMACH. THE TIP WAS PASSED VIA BOWEL MOVEMENT ON (B)(6) 2025. - NO FURTHER FOLLOW UP WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22173731 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.